Single Incision Laparoscopic Surgery (SILS) where a single incision in the umbilicus is all that is used to remove the appendix. The specific methods (staple/tie/port use/etc) will vary depending on surgeon.

This is a prospective, randomized clinical trial involving patients who present to the hospital with non-perforated appendicitis. We will offer enrollment to several institutions provided they receive institutional approval.

There are likely several parameters that will show small differences between groups, and this study will precisely quantify them to allow for adequate consultation from surgeons to families dealing with acute appendicitis. One theoretical concern over the SILS approach is that the exposure of the appendix to the wound could increase the rate of infectious complications; therefore, this is the primary outcome variable. The documented rate of infectious complications at our institution in patients with non-perforated appendicitis is 0.6%. An unacceptable and clinically relevant rise to 5% may curtail enthusiasm for the new technique. Using a power of 0.9 with an α of 0.05, the sample size is 360 total patients or 180 in each arm.

After the procedure, both groups will be managed in the same manner per routine care. They will be discharged when tolerating a regular diet and their pain is well-controlled on oral pain medication. Cosmetic scores will be obtained at 6 weeks and 6 months.

Eligibility

Ages Eligible for Study:

1 Month to 18 Years

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Children under 18 years

Non-perforated appendicitis

Exclusion Criteria:

Perforated appendicitis as identified as a hole in the appendix for fecalith in the abdomen

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00981136